Naveen Kumar S
Hyderabad
Summary
Energetic quality and regulatory professional with 10 years of experience in Design and Development of Medical Domain MDR - Tech file Remediation, MDR-PMS-CMPH (Post Market Surveillance - Complaints Handling). Proven track record of delivering value through collaboration, strong interpersonal skills, and adept multitasking. Committed to prioritizing patient well-being in every task, consistently meeting tight deadlines and swiftly mastering new skills.
Overview
10
10
years of professional experience
Work History
Senior Associate
Freyr Software Services Pvt Ltd
Hyderabad
03.2022 - Current
- Expertly managed the end-to-end complaint handling process for Class II medical devices, including receipt, investigation, root cause elucidation, and adverse event reporting to regulatory authorities such as USFDA, EU, Health Canada, ANVISA, CFDA, PMDA, etc.
- Working on multiple phases of Complaint handling such as Complaint remediation, MDR (Medical Device Reporting) & Quality for Ear, Nose and Throat Products (ENT) & Infusion pump modules.
- Worked on L1(Adverse events) & L2 (Service Complaints) stages and directly submitting to the FDA.
- Leads the development of the Pre-market Product Performance Analysis, Risk Management Plan, Hazard Analysis, DFMEA, UFMEA, coordinating input from the other design sub-team members and supports the development of the PFMEA.
- Responsible for developing Post market surveillance deliverables PMS plan, PMS Report and PSUR for medical devices for remediation projects.
- Played a pivotal role as a CAPA owner and provided support during MDSAP audits by meticulously reviewing SOPs and associated GXP documents, aligning them with EU regulations and ISO 13485:2016 standards.
- Demonstrated leadership by training and mentoring new recruits, fostering a culture of continuous improvement, consistently reflecting the commitment to Medtronic's mission of "Putting Patients First" in all deliverables.
- Managed team resources, including assigning tasks, monitoring progress, and ensuring deadlines were met.
Member of Technical Staff
HCL Technologies Ltd
Madurai
11.2018 - 03.2022
- Creating 3D model for NPD Medical devices with Medical and Mechanical standards.
- Creation of F-S813 'Design Change Evaluation Form' for CE-marking for Class 1 medical devices.
- Assign project resources according to the approved project plan and estimation based on the Priorities.
- Review & Approve the Engineering drawings in PLM/Agile and PLM/Windchill, DCR/DCO's and/or CR/CN's.
- Intake, processing of complaints in the application and follow up for the required data for complaint intake and investigation.
- Investigating and Failure analysis of recalled products and devices, identifying the root cause and analyzing CAPA, Codes of failure.
- Working on multiple phases of Complaint handling such as Complaint remediation, MDR (Medical Device Reporting) & Quality.
- Risk Management Plan- Finding the intended uses and other documents related, Risk analysis, Risk evaluation, Risk estimation against risk criteria, Risk controlling-DFMEA.
- Experienced in performing risk gap analysis by verifying whether all the documents are compliance with GSPR
- Solved most of the Internal & External CAPA's by 5-WHY analysis.
Junior Quality Engineer
Steer Engineering Pvt Ltd
TN
12.2017 - 11.2018
- Lead a team of 8 members to provide a Good Quality of products as per customer specifications
- Approving the Components of Twin-Screw Extruder such as Barrels, Gear box, Shafts with respect to the customer specification drawings using Trimos, Variable and Attribute gauges
- Reviewing and solving the customer complaints using 8D, 5-Why and by raising CAPA
- Reviewing and approving the Inward Inspection of foundry components
- Continuous improvement in Process and Product audit.
Graduate Engineering Trainee
Sakthi Auto Components Ltd
TN
11.2015 - 12.2017
- Responsibility of work is to verify the Layout of a component like Steering Knuckle, Brake Disc and Brake Drum for Multinational Car companies like Maruti, Honda, Ford, General Motors, Ashok Leyland, Toyota, Volkswagen, Hyundai, Renault Nissan, Mahindra & Mahindra, Volvo using Variable and Attribute gauges
- To carry out Dimensional inspection and Final inspection for Casting and Machined components as per customer requirements
- To carry out In-Process Inspection as per drawing standards
- Depth of knowledge about Geometric Dimension and Tolerance (GD & T)
- Experience to solve Customer Complaints and Corrective Actions by using 5-why analysis, 8D
- Knowledge on Measurement System Analysis (MSA) and PPAP
- Experience to prepare Layout Inspection Report (LIR) and Control Plan
- To Carryout Product Audit
- Handle all Attribute and Variable gauges to measure the component as per drawing
- Dispatching Components to various country under standard label provided by the Customer
- Deals with Customer when Customer Complaints arrives and take corrective action using Quality Tools.
Trainee Engineer
KST Windmill Engineering Pvt Ltd
TN
05.2014 - 11.2015
- Role in this Organization was to Design Blade and Nosecone of a windmill
- Here we used Polymer resin and Fiber material to manufacture such product.
Education
Bachelor of Mechanical Engineering -
Kathir College of Engineering
Coimbatore, Tamil Nadu05.2014
Skills
- ISO 13485
- EU MDR
- ISO 14971
- Design Quality, PMS, DFMEA
- Complaint Handling
- 21 CFR 820
Disclaimer
I hereby declare that all the statements made above are true to the best of my knowledge.
Timeline
Senior Associate
Freyr Software Services Pvt Ltd
03.2022 - Current
Member of Technical Staff
HCL Technologies Ltd
11.2018 - 03.2022
Junior Quality Engineer
Steer Engineering Pvt Ltd
12.2017 - 11.2018
Graduate Engineering Trainee
Sakthi Auto Components Ltd
11.2015 - 12.2017
Trainee Engineer
KST Windmill Engineering Pvt Ltd
05.2014 - 11.2015
Bachelor of Mechanical Engineering -
Kathir College of Engineering
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